Model Number 304-30Device Problems Inappropriate Shock; Material Protrusion / Extrusion Event Date 04/01/2015Event Type Injury Event Description It was reported that the patient underwent a full revision surgery on (b)(6) 2015 due to reported pain and shocking sensations. It was reported the surgery was performed for patient comfort. It was also reported that the patient's new vns system was programmed on after surgery and the shocking sensation appeared to have resolved. Neither the lead nor the generator have been received to date.

Manufacturer Narrative

Event Description It was reported that the patient has been feeling 'shocks' in the neck at the electrode area for the last few months. X-rays were taken with no issues noted with the vns device. The vns device was tested by the physician with no issues noted. It was also reported that the patient had surgery on his esophagus on (b)(6) 2015, which has caused a 70 lbs. Weight loss and is causing the generator and lead to protrude. The 'shocks' started sometime after this procedure. It was reported that the pain doesn't happen all the time, but is often, and not with every stimulation. It was reported that the patient had the vns device diagnostics run while the patient was turning his head in multiple directions and there was no change in the impedance value. It was also reported that the 'shocks' stopped when the device was programmed off and the pain only occurs during stimulation. The output current was reduced and the off time was increased on (b)(6) 2015 to try to resolve the pain. The patient stated that the pain decreased but that the pain was still present. The patient was referred for generator replacement. No known surgical interventions have been performed to date.

Event Description Additional information was received on 07/16/2015 from the physician's office. The nurse indicated that the patient's generator was disabled a couple of months prior due to the throat pain he was experiencing. No recent diagnostics were available to provide but it was stated that the device was functioning normally a few months ago. The plan for the patient is to keep the device disabled and try to get him set up for removal of the device although this is not planned to date. She said that the disablement and surgery is both for comfort and to possibly prevent a serious injury from the pain. The patient complained of severe pain in the throat area with stimulation.

Event Description The patient began experiencing painful stimulation in the throat on (b)(6) 2015. Diagnostic results were checked and within normal limits. The patient did not experience any trauma or manipulation that may have contributed. On 06/16/2015 the patient reported that he is planned to have his vns removed and he had a consultation that day in which the physician agreed to the removal. The patient noted that he was planning to have the device removed due to being unable to breathe associated with stimulation. He also has coughing and throat pain associated with vns stimulation. He noted that his diagnostic results, both systems and normal were fine and within range. Follow-up with the physician was unclear on whether the explant is for patient comfort or to preclude a serious injury. Further attempts for additional relevant information have been unsuccessful to date.

Model Number 302-20Event Date 05/22/2009Event Type Injury Event Description It was reported that the patient has been experiencing pain from her neck to her hand that began approximately one month following generator and lead replacement six years prior. The pain began with swelling in the patient's neck, shoulder, and arm, and the patient believes that a nerve was pinched at that time. The patient has been on pain medications and has undergone physical therapy and nerve blocks due to the pain. The patient believes that the vns lead electrodes may have been placed incorrectly and that the placement may be putting pressure on another nerve. The patient indicated that the pain occurs with device stimulation because the pain was exacerbated when the device settings were increased in (b)(6) 2014. The patient reported that the device was programmed off for a while and that the pain subsided a great deal. The device was programmed back on in (b)(6) 2015 and the pain began again in (b)(6) 2015. The physician's office reported that the patient has been seen recently and has not reported these events. The physician's office indicated that the patient would be contacted regarding the reported pain. No additional relevant information has been received to date.

Event Description It was reported that the patient presented on (b)(6) 2015 as an emergency to adjust his vns output current. For three weeks, he had experienced constrictive larynx and was unable to breathe in the morning, per the physician. The output current was decreased from 0. 75ma to 0. 25ma. Additional information was received that the patient was experiencing pain in the throat and jaw with stimulation. The plan was to obtain x-rays of the leads and to discuss the symptoms with the surgeon. Lead impedance was okay with impedance around 3700 ohms. Good faith attempts for additional relevant information have been unsuccessful to date.

Model Number 304-20Event Date 06/01/2014Event Type Injury Event Description During an appointment on (b)(6) 2014, the patient reported that there is a "problem with the lead" that started approximately two weeks prior. She could feel pain in ear and at the clavicle area with stimulation, but it was unclear whether it was with every stimulation on-time; however, the patient noted she could feel the stimulation on-times normally. There was no known preceding trauma, but does have a (b)(6) old and has gained weight recent. Diagnostics indicated an impedance of 2040 ohms which was within normal limits. The vns output current was lowered to 1. 25ma, which lessened the pain by the patient. Lead revision was going to be considered. Additional information was later received on 08/13/2015 indicating that the patient s device was turned off with only the magnet still on. The patient was referred for vns replacement surgery. It was noted that the patient previously wanted the device explanted, but the physician persuaded her to keep it. During system diagnostics, the patient reported pain again. No surgical intervention has occurred to date.

Manufacturer Narrative

Event Description The patient later had lead replacement surgery. Pre-operatively, lead impedance was reported to be okay. The surgeon opted to not replace the generator, as he was not sure based on her previous tolerability whether putting in another brand new generator was appropriate. The explant hospital will not return explanted products per hospital policy, so analysis is unable to be performed. No additional relevant information has been received to date.

Event Description Initially, it was reported that the patient underwent device explant for an unknown reason. Further follow-up revealed that the vns system was explanted because the device had been programmed off for some time because it was painful when the device was on. It was noted that during explant there was a lead fracture visualized by the surgeon near the neck area. The patient was not reimplanted. The explanted lead and generator were received for analysis. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

Event Description Follow-up revealed that the patient first reported painful stimulation in the neck during an office visit on (b)(6) 2013. The device was subsequently disabled. No diagnostic tests were performed that day. The last diagnostic test was performed on (b)(6) 2013 which showed normal device function at that time and the device had not been tested since device disablement.

Model Number 302-20Device Problems Detachment Of Device Component; High impedance Event Date 07/17/2015Event Type Malfunction Event Description Additional information was received that the patient's pain had been occurring in the patient's neck prior to the generator and lead replacement surgery. The pain began occurring following a settings increase. Thus, the settings were decreased which helped the pain. The pain was thought to perhaps have been caused by the detached electrode. No additional relevant information has been obtained to date.

Event Description Analysis was completed on the patient's explanted generator. Analysis showed that the generator performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. An analysis was performed on the returned lead portion. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

Event Description Clinic notes were received and indicated that the patient had experienced pain associated with stimulation. There was also a report of a settings adjustment which helped with the pain. The patient then underwent a prophylactic generator replacement surgery on (b)(6) 2015. However, pre-operative system diagnostics resulted in high impedance detected on the patient's vns system. Thus, the lead was replaced as well. It was reported that during the lead replacement, it was seen that the positive electrode and anchor tether of the lead had become detached from the patient's vagus nerve, leaving only the negative helical electrode still attached. No lead fractures were noted. It was unknown how the lead had become partially detached form the nerve. The diagnostics were normal following the generator and lead replacement. The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date.

Model Number 105Device Problem Adverse Event Without Identified Device or Use Problem Event Date 07/13/2015Event Type Injury Event Description It was later reported by the physician that he does not believe the patient's reported pain is related to vns. It was also reported that system diagnostics were normal and the impedance value was normal. It was noted this patient has a number of psychological issues. No other additional relevant information has been reported to date.

Manufacturer Narrative

Manufacturer Narrative The udi number was inadvertently left off of the initial mfr. Report. (b)(4).

Event Description It was reported that the patient visited the er as she was experiencing an altered perception of stimulation as it was stated she could feel it, go off, every 30 seconds; however, the patient claimed the neurologist had set the device to go off every 3 minutes. It was also noted that this stimulation was painful. During this visit to the er, she was given ativan for her anxiety. The patient visited the er the following day with the same complaints. She also stated the ativan was not helping; however, later she states that she felt much better after her shot of ativan. The patient then stated that she does not usually have an aura, but she now has a sense of smell and burnt toast almost all the time recently. It was also reported that the patient has some discomfort earlier in her chest radiating to the left shoulder. There was no additional information on the chest pain other than it was not related to exertion or breathing. The patient's pain was treated with dilaudid. It was noted that the patient's device has been checked several times since it was implanted in (b)(6) of 2014 and there have been no issues. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description It was reported by the patient's following physician that the er physician had said the patient's smell of burnt toast was not related to seizures. However, it was noted by the patient's following physician that this was new to the patient after the patient was seen and assessed on (b)(6) 2015. Additionally, the physician explained that the patient has a history of anxiety issues which is the cause of the patient's complaint of the vns device firing too often. No additional relevant information has been received to date.

Manufacturer Narrative Results; this information was inadvertently left off of the supplemental #02 mfr. Report.

Model Number 103Device Problem Adverse Event Without Identified Device or Use Problem Event Date 07/21/2015Event Type Injury Event Description It was reported that the patient experienced pain associated with stimulation in her neck and left arm. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Manufacturer Narrative

Manufacturer Narrative Event description; corrected data: the previously submitted mdr inadvertently did not specify the pain associated with stimulation in the patient¿s neck and left arm.

Event Description It was reported that the vns patient was experiencing painful, erratic stimulation from her device. Clinic notes were received indicating that the patient's device showed normal device function and an ifi condition during an office with on (b)(6) 2015. The patient presented with a sore throat which involved occasional pain in the throat from stimulation on-times. The physician attributed the issues to the device nearing end of service and referred the patient for surgery. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2015. The explanted generator has not been returned to date.

Model Number 302-30Device Problem Positioning Problem Event Date 09/03/2015Event Type Malfunction Event Description Additional information was received that the patient was hyper-sensitive to the pain, so initially it was believed that there was nothing wrong other than the presence of the device causing pain. It was reported that the patient underwent generator replacement surgery on (b)(6) 2015 due to the chest pain as well as painful stimulation. Pre-operative diagnostics revealed normal impedance of 1,590 ohms. During the replacement surgery, the surgeon observed a crack in the lead insulation with some fluid inside. There was no known trauma which caused this. The lead was not revised.

Event Description It was reported that the patient was having pain at her vns generator implant site and thus was wanting the device repositioned. No known surgical interventions have occurred to date. No additional relevant information has been obtained to date.

Model Number 103Device Problem Programming Issue Event Date 08/03/2012Event Type Injury Event Description Clinic notes were received indicating that the vns patient's device settings were adjusted on (b)(6) 2013 and the patient tolerated the adjustment well. The physician commented that the patient's pulse width was programmed to low settings likely due to unspecified tolerability issues when the device was implanted. Programming history in the clinic notes showed that the device pulse width was programed to 250usec from (b)(6) 2014 through (b)(6) 2015. Review of the available programming and diagnostic history showed that the device pulse width was programmed to 250usec. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description Follow-up revealed that the tolerability issues were referring to painful stimulation when the device pulse width was increased greater than 250usec. The pulse width was reduced back to 250usec. The physician did not consider this an issue but an expected side effect of device stimulation. System diagnostic results had shown normal device function throughout the years and the patient was doing well.

Model Number 103Device Problem Migration or Expulsion of Device Event Date 09/03/2015Event Type Injury Event Description The patient did not have her surgery has scheduled. The patient has had medication issues which were a factor in the decision not to perform surgery. No additional relevant information has been received to date.

Event Description Patient underwent generator replacement surgery. The explanted generator has not been received to date.

Event Description It was reported on (b)(6) 2015 the patient had come in the day prior and was complaining of radial arm pain. The vns device was interrogated and system diagnostics were run and everything was fine. It was discussed that the patient had lost over (b)(6) lbs since implantation and the device has moved medially. It is right on her chest bone now. The physician thinks that her arm pain might be due to the device moving and putting pressure on a nerve. He is referring her to a neurosurgeon for a revision of the placement of the generator. No additional relevant information has been received to date.

Manufacturer Narrative

Event Description Additional information was received that patient is having her device revised due to the fact that the patient has lost weight and the device has migrated. It was also reported the patient is feeling pain and choking during stimulation.

Model Number 300-20Event Date 07/15/2015Event Type Malfunction Event Description On (b)(6) 2015 it was reported that the patient has high impedance. Normal mode diagnostics were performed which showed a dcdc of 7 and output=limit. The patient also reported painful stimulation. His report of the location of pain varies, but it does appear to occur when the device turns on. He reported that it's in his neck, then his head, and then his chest. They didn't want to perform system diagnostics due to the patient's report of painful stimulation at settings lower than the system diagnostic test settings. It was also noted that the patient has voice alteration when the device cycled on. The vns device was left on at the patient's request. The patient was referred to a surgeon. Although surgery is likely, it has not occurred to date. The physician reported that no patient manipulation or trauma occurred. She noted that a ct scan had been performed on the patient but not x-rays.

Manufacturer Narrative Device failure is suspected, but did not cause or contribute to a death or serious injury.

Model Number 304-20Device Problem Adverse Event Without Identified Device or Use Problem Event Date 09/08/2018Event Type Injury Event Description Patient reported experiencing tightening of the lead wire with simulation which causes ear pain. The patient was referred for generator replacement due to low battery and lead replacement due to the pain. No known surgical intervention has occurred to date. No other relevant information has been received to date.

Model Number 302-20Device Problem High impedance Event Date 01/09/2019Event Type Malfunction Event Description It was reported that the patient was seen again after a lead pin reinsertion surgery, and high impedance was observed. Diagnostics further noted that the output current was not delivering and the patient was complaining of a shocking sensation to her neck. The patient was sent for x-rays and was to be referred for possible lead revision surgery. Clinic notes from the office visit were received and reviewed. It was stated that since the patient's last visit, the patient was experiencing an intermittent "shocking" sensation at the left side of the neck, coughing more, and had chocked while eating three times, one of which became cyanotic and required a heimlich maneuver. The noted diagnostics confirmed the high impedance and low output current delivered that was reported. It was stated that x-rays of the chest and neck showed no apparent lead break. Settings were decreased for the adverse event of painful stimulation, coughing, and choking. Ap and lateral chest and neck x-rays were received for review. The generator placement appeared to be normal in the left axillary chest area. Due to the quality and angle of the images provided, complete lead pin insertion and feed-through wire integrity could not be assessed. The lead was observed in the patient¿s neck appeared to be routed toward the patient¿s left chest. Due to the quality and angle of the image, strain relief and integrity of the lead could not be assessed. A portion of the lead is routed behind the generator. Based on the images provided, no obvious cause of the adverse events or high impedance was identified. Note that the presence of a gross fracture in the portion of the lead excluded from the images or a micro-fracture along the lead body cannot be ruled out. Revision surgery occurred and it was noted that the explanted product was not expected to be returned for analysis as the hospital discards products after surgery. It was specified that only the lead was revised, with the replacement lead placed on the left vagal nerve. Pin reinsertion was not tested. No device was received to date. No additional relevant information was received to date.

Model Number 106Device Problem Appropriate Term/Code Not Available Event Date 12/18/2018Event Type Malfunction Event Description It was reported during a generator replacement surgery due to painful stimulation, indicated to be for patient comfort and not to preclude a serious injury, that a dark spot was seen on the generator being explanted. The surgeon stated the spot may have been due to the device being hit with bovie, a form of electrocautery, however he was unable to confirm this. The explanted generator was shipped back for analysis and received. It was confirmed that the pre-operative diagnostics and settings were within normal limits. Follow-up with the patient's neurologist also noted ok diagnostics prior to surgery. The implant card was received for the surgery indicating the surgery was prophylactic. Analysis of the returned generator has not been completed to date. No additional, relevant information was received to date.

Model Number 304-20Device Problem Fracture Event Date 01/01/2019Event Type Malfunction Event Description It was reported that high impedance was observed on the patient's vns. The patient's vns was programmed off and the patient was referred for a consult. A review of device history records revealed that the generator and lead passed quality control inspection prior to distribution. The patient underwent vns lead replacement surgery due to an observed lead fracture. The patient also had reported feeling painful stimulation in his neck. The explanted lead has not been received by the manufacturer to date. No additional relevant information has been received to date.

Model Number 1000Device Problem Adverse Event Without Identified Device or Use Problem Event Date 01/08/2019Event Type Injury Event Description Initial report was that a patient was referred for device removal due to the device not helping the patient and hurting when going off. The device was disabled. No known surgical intervention has occurred to date. No other relevant information has been received to date.

Model Number 304-20Device Problem Adverse Event Without Identified Device or Use Problem Event Date 01/10/2019Event Type Injury Event Description It was reported that the patient experienced painful stimulation/shocking in the neck when the magnet was swiped over the generator and their pain management physician requested information about explanting the patient's generator. It was reported that the patient had been strangled and that the nurse believed the patient's lead may be broken due to the reported assault. It was additionally reported that the patient's lead was bent and was "poking out. " clarification from the medical professional indicated that the device was not coming out of the skin. The patient no longer felt the vns cycle like she had in the past. No known surgical intervention has occurred to date. No further relevant information has been received to date.

Model Number 106Device Problem Adverse Event Without Identified Device or Use Problem Event Date 01/10/2019Event Type Injury Event Description Initial report was that a patient was feeling pain when the device "goes off. " the patient was referred by her neurologist to a neurosurgeon. It is unclear if intervention was taken or what type of intervention is planned at this time. No known surgical intervention has occurred to date. No other relevant information has been received to date.

Model Number 105Device Problem Adverse Event Without Identified Device or Use Problem Event Date 08/24/2015Event Type Injury Event Description Additional information was received that the patient saw his neurologist one day following the er visit. The neurologist adjusted the vns settings, which reportedly resolved the patient's pain. The physician believed the pain was simply related to normal vns stimulation. The setting adjustment was reportedly performed for patient comfort, not to preclude a serious injury. No additional relevant information has been obtained to date.

Event Description It was reported that the patient was admitted to the er due to painful stimulation at the chest vns generator site. System diagnostics were run and were within normal limits including impedance which was 1888 ohms. It was reported that the patient had a sternal rub the day before and the pain has been occurring since then. Settings were reported as 1/75/20/500/60/1. 8, 2/60/500. The device was then disabled.

Model Number 105Event Date 01/01/2015Event Type Injury Event Description It was reported by the physician the patient had her generator and lead explanted on (b)(6) 2015 due to painful stimulation at the generator site. It was also reported the patient had pain in her left neck at the incision site. It was reported the patient first began having pain around (b)(6) 2015. Attempts for additional relevant information have been unsuccessful to date.

Model Number 103Device Problem Insufficient Information Event Date 08/17/2015Event Type Injury Event Description It was reported by a provider that a patient was experiencing pain at the generator site neck and the surgeon was planning to perform a surgical revision. The physician noted a nodule under the skin which did not cause pain upon palpation but the patient stated it was painful at other times. It was reported that the patient was having seizures whereas during a recent storm he only had one seizure. The patient's device normal mode and magnet mode output currents were decreased. Normal lead impedances were reported, however, neos status 3 days post-implant was yes but at subsequent device checks was no. Attempts for additional relevant information have been unsuccessful.

Event Description Follow up with the provider indicated that the pain at the generator site was due to the presence of the generator. The neck pain was due to vns stimulation which was addressed by reducing device output parameters. The nodule was stated to be unrelated to the patient's vns system. It was stated that the patient only experienced increased seizures during storm activity and the overall seizure frequency was below the patient's pre-vns rate. The provider clarified that the battery status 3 days post-implant should have indicated no instead of yes. The provider stated that the surgical revision was for patient comfort purposes and to utilize the latest vns technology and not to preclude a serious injury. The provider stated that the lead would only be replaced if an issue was discovered with the lead intra-operatively as the most recent device check indicated normal lead impedance.

Event Description Information was received indicating that the patient's pulse generator was successfully explanted and replaced as previously planned due to the patient report of pain. The patient's lead was not replaced. Lead impedance with the newly implanted generator was within normal limits. The explanted pulse generator was returned to the manufacturer and is currently undergoing product analysis.

Event Description No performance or any other type of adverse conditions were found with the pulse generator and a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. The battery voltage battery was calculated to be 2. 967 volts and the battery shows an ifi=no condition. Measured battery voltage and consumed capacity parameters are as expected.

Event Description It was reported that low output current and high impedance was identified during interrogation of a patient. The patient's settings were adjusted, which temporarily resolved the low output current, but the high impedance was still present. X-rays were taken, but the cause of the high impedance could not be identified. The patient also reported feeling mildly painful stimulation one time at the generator site and itching at the neck during interrogation. The patient's device was programmed off until the cause of the high impedance, itching, and pain could be identified and fixed. Surgery to determine the cause of the high impedance is expected, but has not occurred to date.

Model Number 102Event Date 01/01/2013Event Type Injury Event Description It was reported that the vns patient underwent surgery on (b)(6) 2015 to explant her generator. The explanting facility discarded the explanted device; therefore, no analysis can be performed. Follow-up revealed that the patient's device had been disabled for years due to painful stimulation. The patient later reported having pain at the generator site so the surgeon elected to explant to device. Attempts for additional relevant information have been unsuccessful to date.

Model Number 103Device Problem Insufficient Information Event Type Injury Event Description It was reported the patient was experiencing painful stimulation. The patient was referred for exploratory surgery and possible device replacement. It was reported the patient's device had no high impedance but the physicians opted to completed a prophylactic replacement anyway. Once the new generator was replaced, the impedance was once again within normal parameters. Attempts for additional relevant information have been unsuccessful to date.

Model Number 302-20Event Date 07/04/2005Event Type Malfunction Event Description During review of the programming history it was noted that he patient had high impedance. The patient had previously reported a lack of efficacy and painful stimulation in her chest as well as reporting that she did not feel magnet and normal stimulation. The patient had the generator and lead explanted due to the lack of efficacy. Product return attempts are in process. Follow-up with the treating neurologist at that time indicated that they had not seen the patient in a number of years and they no longer have any records for the patient. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

Event Description Additional information indicated that the generator and lead were likely discarded. The hospital does not return explanted product due to the time and cost factor.

Manufacturer Narrative Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

Model Number 105Device Problems Generator; Device Operates Differently Than Expected Event Date 11/05/2015Event Type Injury Event Description It was reported that a patient felt shocking sensations in the neck. The patient's settings were decreased, which temporarily resolved the issue. However, the patient later reported that she felt like she was being stabbed in the neck. The patient was referred for possible generator replacement surgery due to the painful stimulation. The physician most likely believes that the potential cause of the painful stimulation is the generator, since they referred the patient for generator replacement surgery. No surgical intervention has occurred to date.

Event Description The patient's neurologist referred the patient for surgery due to the painful stimulation, but it was only for patient comfort. However, when the patient had a consult with the surgeon, only the patient's settings were adjusted. The surgeon ran system diagnostics, which were within normal limits, and adjusted the patient's settings in response to the painful stimulation. No surgical intervention has occurred to date.

Event Description It was reported that the patient fell and was complaining of painful stimulation. The patient also reported that her physician reported "crazy diagnostics" on the patient's vns, although it is unknown what the diagnostics were. No additional relevant information has been obtained to date.

Event Description It was reported that the vns patient was feeling of sporadic and painful stimulation. It was reported that patient seizures are well controlled and patient has been seen a huge improvement with the vns therapy. It was reported that patient underwent generator replacement for prophylactic reason (b)(6) 2015 and the adverse events persist. The explanted generator was reported as disposed of by the hospital and will not be returned to the manufacturer. Further information was received that the intense stimulation continues with the new generator. It was also reported that patient had increase in seizures; the current seizure rate is above pre-vns levels. It was reported that the medical professional suspects a problem with the lead such as current leakage which may not appear on the diagnostic test, therefore evoked potential test in various positions will be performed. It was reported that regardless of outcome evoked potential outcome, lead revision is expected. No known surgical interventions have occurred to date.

Manufacturer Narrative Age at time of event and date of birth; corrected data: the previously submitted mdr inadvertently provided an incorrect age at time of event and date of birth.

Event Description Further information was received from the physician, indicating that a new diagnostic test was performed and returned impedance results within normal limits with 1344 ohms. An emg-based lead test was also performed which resulted to be normal. It was reported by the physician that, despite these results, they decided to replace both the lead and the generator (since the lead is 18 year old). No known surgical intervention has occur to date.

Event Description An implant card received by the manufacturer and the review indicates that the vns patient underwent full revision surgery on (b)(6) 2016 and that the re-implant was due to lead break. The lead impedance for the new implant was marked as ok - 1486 ohms. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description A return good authorization number request was received by the manufacturer to return the explanted generator model 104 serial number (b)(4) implanted with the suspect device involved in the present case. Return of the generator for analysis is expected, but it has not been received to date.

Event Description Portion of the suspect lead was received by the manufacturer. The explanted generator was received as well. It was reported that the reason for replacement is patient experiencing stimulation more than expected: side effect of a leak of electricity. Analysis of the suspect lead was completed and the allegations were not verified within the returned lead portions. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. Review of manufacturing records confirmed all tests passed for the lead prior to distribution.

Event Description Analysis was completed on the explanted generator and reported allegation of "high impedance" was not duplicated. Review of the data downloaded from the generator shows a possible indication of increased impedance from a value of 1305 ohms, to a value of 22812 ohms, and the time of change detection was (b)(6) 2016 (generator explant on (b)(6) 2016). The vns programming history database shows the last known diagnostic test was performed on (b)(6) 2015 with an impedance value of 1357 ohms (implant (b)(6) 2015 / explant (b)(6) 2016). Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, the battery status was ifi no. The data in the "diagaccumconsumed" memory locations revealed that 16. 488% of the battery had been consumed.